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Sponsors and Collaborators: |
Procter and Gamble Sanofi-Aventis |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00699777 |
This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: Risedronate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects |
Enrollment: | 96 |
Study Start Date: | January 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
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Drug: Risedronate
1 risedronate 150 mg tablet administered orally
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2: Active Comparator
Two risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
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Drug: Risedronate
2 risedronate 75 mg tablets administered as a single oral dose
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The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Research Site | |
Gainesville, Florida, United States | |
Research Facility | |
Miramar, Florida, United States | |
United States, Texas | |
Research Facility | |
Dallas, Texas, United States | |
Research Facility | |
Austin, Texas, United States |
Study Director: | William S Aronstein, PhD/M/FACP | Procter and Gamble |
Responsible Party: | Procter & Gamble ( William S Aronstein, PhD, MD, FACP ) |
Study ID Numbers: | 2007141 |
Study First Received: | June 16, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00699777 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic |
Healthy Bone Diseases Risedronic acid |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |